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By now, many of you will have heard that an independent FDA advisory committee unanimously recommended the return to market of Tysabri (natalizumab) for relapsing forms of MS. The drug had been voluntarily taken off the market in February 2005 because of several cases of a serious brain disorder called progressive multifocal leukoencephalopathy, or PML. It is estimated, based on available data, that the risk of developing this disorder is 1 in 1,000. But for some patients who do not get enough relief from currently available medications, this risk may well be worth taking. This will require a careful risk-benefit analysis tailored specifically to each patient's condition.

While not guaranteed, FDA approval following an advisory committee's recommendation is usually the rule. It's likely that the drug's sponsor and the FDA are working out details of how the prescribing information will read and what risk management program they will put in place to monitor patients. It is hoped that FDA approval may come by June.

On a negative note, Teva Pharmaceuticals announced on March 21, 2006, that it was stopping development of an oral formulation of Copaxone (glatiramer) because the formulation did not live up to expectations for effectiveness. Currently, all of the so-called platform drugs for MS, the interferons and Copaxone, as well as Novantrone (mitoxantrone) and Tysabri must be taken by injection or IV infusion. An oral formulation would have likely been very popular, however, hopes for that will have to be put on hold for now.

Last Updated:3/27/2006

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